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Last Updated: March 14, 2025

LEVORPHANOL TARTRATE Drug Patent Profile


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DrugPatentWatch® Litigation and Generic Entry Outlook for Levorphanol Tartrate

A generic version of LEVORPHANOL TARTRATE was approved as levorphanol tartrate by HIKMA on March 31st, 2000.

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Pharmacology for LEVORPHANOL TARTRATE
Drug ClassOpioid Agonist
Mechanism of ActionFull Opioid Agonists
Medical Subject Heading (MeSH) Categories for LEVORPHANOL TARTRATE

US Patents and Regulatory Information for LEVORPHANOL TARTRATE

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Hikma LEVORPHANOL TARTRATE levorphanol tartrate TABLET;ORAL 074278-002 Jun 18, 2018 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Specgx Llc LEVORPHANOL TARTRATE levorphanol tartrate TABLET;ORAL 212024-001 Dec 13, 2019 AB RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Novitium Pharma LEVORPHANOL TARTRATE levorphanol tartrate TABLET;ORAL 213479-003 Jul 20, 2021 RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Sun Pharm Inds Inc LEVORPHANOL TARTRATE levorphanol tartrate TABLET;ORAL 213906-001 Jun 17, 2021 AB RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>TE>Type>RLD>RS>Patent No.>Patent Expiration>Product>Substance>Delist Req.>Exclusivity Expiration
Showing 1 to 4 of 4 entries

Market Dynamics and Financial Trajectory for Levorphanol Tartrate

Introduction

Levorphanol tartrate, a potent opioid analgesic, has been on the market for several decades, offering a unique multimodal profile that sets it apart from other opioids. This article will delve into the market dynamics and financial trajectory of levorphanol tartrate, exploring its clinical utility, market position, and the economic implications of its use.

Clinical Utility of Levorphanol Tartrate

Levorphanol tartrate is distinguished by its multimodal pharmacological effects, which include strong mu, delta, and kappa opioid activities, as well as NMDA antagonist properties. This profile makes it particularly useful for treating complex pain syndromes, including neuropathic and nociceptive pain, and opioid-induced hyperalgesia (OIH)[1].

Efficacy in Pain Management

Studies have shown that levorphanol tartrate can provide effective analgesia in patients who have not responded to other opioids. For instance, a study involving 200 chronic pain patients reported successful analgesia in 79.5% of the cases[1]. This efficacy is crucial in a market where chronic pain affects a significant portion of the population, with the Institute of Medicine estimating that 100 million Americans are affected by chronic pain[2].

Market Position

Unique Selling Points

Levorphanol tartrate's unique pharmacological profile and predictable pharmacokinetics make it an attractive option in the opioid market. Unlike methadone, which has a highly variable pharmacokinetic profile and significant drug-drug interaction risks, levorphanol tartrate has a shorter half-life and no reported effects on the QT interval. This reduces the risk of adverse cardiac events and drug interactions, making it a safer choice for patients with comorbidities[1].

Opioid Rotation

Levorphanol tartrate is well-suited for opioid rotation, particularly for patients whose pain is refractory to other opioids. Its ability to address pain that other opioids cannot, combined with its lower risk of drug-drug interactions, positions it as a valuable alternative in the treatment of chronic pain[1].

Financial Trajectory

Healthcare Utilization and Costs

The financial implications of using levorphanol tartrate are closely tied to its efficacy and safety profile. Studies on chronic opioid use have shown that healthcare resource utilization and costs increase significantly during the first six months of opioid treatment but decline thereafter, though they remain above pre-treatment levels[2].

Cost Analysis

For patients initiating opioid therapy, the costs per patient-year are substantial. For example, all-cause pharmacy costs more than double during the first six months of treatment, and while they decline after this period, they do not return to pre-treatment levels[2]. However, the use of levorphanol tartrate, with its predictable pharmacokinetics and lower risk of adverse events, could potentially reduce long-term healthcare costs by minimizing the need for frequent hospitalizations and additional treatments.

Market Demand

The demand for effective and safe opioid analgesics is high, driven by the prevalence of chronic pain. The economic burden of chronic pain, estimated to exceed $600 billion annually in the United States, underscores the need for cost-effective treatments[2]. Levorphanol tartrate, with its unique benefits, is positioned to capture a significant share of this market.

Economic Burden of Chronic Pain

Direct and Indirect Costs

Chronic pain imposes significant direct and indirect economic burdens. Direct costs include healthcare expenditures such as hospitalizations, outpatient visits, and medication, while indirect costs include lost productivity and social costs. The use of levorphanol tartrate, by providing effective pain relief and reducing the need for multiple medications and hospitalizations, can help mitigate these costs[2].

Global Access and Disparities

Access to Controlled Medicines

There are significant disparities in access to controlled pain medications globally. For example, in West and Central Africa, only four standard doses of controlled pain medication are available per million inhabitants per day, compared to 32,000 doses in North America[3]. Improving access to medications like levorphanol tartrate in these regions could have a profound impact on public health and economic outcomes.

Regulatory and Market Trends

Pharmaceutical Market Dynamics

The pharmaceutical market for opioids is subject to various regulatory and market trends. The COVID-19 pandemic has influenced prescription patterns, with telemedicine playing a more significant role in prescribing controlled substances. However, the overall trend shows an increase in the use of opioids for chronic pain management, which bodes well for the market position of levorphanol tartrate[4].

Conclusion

Levorphanol tartrate's unique pharmacological profile, efficacy in treating complex pain syndromes, and predictable pharmacokinetics make it a valuable asset in the opioid market. Its potential to reduce healthcare costs by minimizing adverse events and the need for multiple treatments positions it favorably in a market where the economic burden of chronic pain is substantial.

Key Takeaways

  • Unique Pharmacological Profile: Levorphanol tartrate has strong mu, delta, and kappa opioid activities, as well as NMDA antagonist properties.
  • Efficacy in Pain Management: Effective in treating neuropathic and nociceptive pain, and opioid-induced hyperalgesia.
  • Predictable Pharmacokinetics: Shorter half-life and lower risk of drug-drug interactions compared to methadone.
  • Cost-Effective: Potential to reduce long-term healthcare costs by minimizing adverse events and hospitalizations.
  • Market Demand: High demand driven by the prevalence of chronic pain and the economic burden associated with it.

FAQs

What is the primary use of levorphanol tartrate?

Levorphanol tartrate is primarily used for the management of chronic pain, particularly for pain syndromes that are refractory to other opioids.

How does levorphanol tartrate differ from other opioids?

Levorphanol tartrate has a unique multimodal pharmacological profile, including strong mu, delta, and kappa opioid activities, as well as NMDA antagonist properties, which sets it apart from other opioids.

What are the economic implications of using levorphanol tartrate?

The use of levorphanol tartrate can potentially reduce long-term healthcare costs by providing effective pain relief, minimizing adverse events, and reducing the need for frequent hospitalizations and additional treatments.

Is levorphanol tartrate widely available globally?

There are significant disparities in access to controlled pain medications globally, with limited availability in many regions, particularly in West and Central Africa.

How has the COVID-19 pandemic affected the market for levorphanol tartrate?

The COVID-19 pandemic has influenced prescription patterns, with an increased role for telemedicine in prescribing controlled substances, but overall, the demand for effective opioid analgesics like levorphanol tartrate remains high.

Sources

  1. MedCentral: Levorphanol: An Optimal Choice for Opioid Rotation.
  2. American Journal of Managed Care: Treatment Patterns, Healthcare Utilization, and Costs of Chronic Opioid Treatment for Non-Cancer Pain in the United States.
  3. United Nations Office on Drugs and Crime: Drug Market Trends: Cannabis Opioids.
  4. IQVIA Report: Stimulant Trends from 2012 - 2022.
  5. Roxane Laboratories: LEVORPHANOL TARTRATE Tablets USP, 2 mg.

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